SR. EXECUTIVE, REGULATORY AFFAIRS

Job title.
Sr.
Executive, Regulatory Affairs Overall purpose of job.
•         Regulatory and quality compliance for the entire Johnson & Johnson Medical franchises in India •         To maintain the Life cycle management of the product registered by Johnson & Johnson •         Developed regulatory strategies along with internal stakeholders to coordinate and mitigate interdependencies of overlapping projects to successfully submit application to HA averting any business impact •         Ensures compliance with regulatory agency regulations and interpretations Essential duties and responsibilities.
•         Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer) for India market.
•         Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India market in accordance with applicable regulations and relevant guidelines.
•         Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise.
•         Update and live maintenance of business plan in sharepoint for assigned franchises/ licenses.
•         Assist in the preparation of technical presentations/ meetings with regulator.
•         Ensures compliance with regulatory agency regulations and interpretations.
•         Gathers and assembles information, prepares documents for New Product applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines.
•         Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management) •         Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/franchises.
•         Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations •         Maintenance of RA database for the responsible franchises in MDRIM tool.
•         Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals.
•         Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system.
•         Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure.
•         Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/ other portal.
•         Ensure on time archival of regulatory submission documents.
•         Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner.
•         Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware.
•         Other assignment identified and assigned by Supervisor/ management- time to time.
Special requirements.
•         Strong knowledge of Medical Device Rule and Drugs and Cosmetics Act •         Knowledge in the international regulations of Medical Devices in US and EU •         Sound knowledge on Medical Device Quality Management System ISO •         Excellent proficiency with software tools Job location.
Gurgaon, Haryana- India Qualifications Essential knowledge and skills.
•         Graduate/ Post Graduate in Lifescience/ Bio Medical/ Pharmacy •         Minimum 2-6 years Industry Experience in Regulatory Affairs, preferably in medical devices.
Sound understanding of MD rules and regulations in India.
•         Experience of Submitting, Registering and maintaining Product registrations with MOH •         Experience in quality/ manufacturing and regulatory affairs in medical devices would be advantage •         Experience in assembling product dossiers for submission to Regulatory Authorities.
•         Good technical writing and communication skills.
Core competencies required for this role.
•         Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook •         Translate insights into innovative and viable products or solutions that create value •         Challenge the status quo; lead and adapt to change Engage in transparent and constructive conversations